Method Development & Validation
● Custom analytical methods designed for your API and formulation
● Method validation to ICH and FDA guidelines, ensuring regulatory acceptance
● Remediation of outdated or non-compliant analytical methods
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Analytical Chemistry Services
Capabilities in Analytical Chemistry and Method Development
CMC Pharma provides comprehensive analytical services to support every stage of drug product development, from preclinical feasibility to commercial readiness. Our team specializes in developing, validating, and executing analytical methods that ensure the quality, safety, and efficacy of your pharmaceutical product.
We deliver more than routine analytical testing. Our services extend to GMP-compliant release testing, dissolution testing, and robust method development and validation, all designed to accelerate your development timeline while meeting FDA and ICH regulatory expectations.
With decades of expertise in analytical chemistry, we combine scientific rigor with regulatory insight to de-risk your program and ensure your drug product advances smoothly toward approval.
The Importance of Analytical Services in Drug Development
Analytical chemistry testing is the foundation of pharmaceutical development and regulatory success. Robust, validated analytical methods are critical for understanding drug stability, ensuring product consistency, and meeting stringent global quality standards.
Whether you need a new analytical method developed from scratch, remediation of legacy or compendium methods, or GMP lot release testing for clinical supply, CMC Pharma provides stage-appropriate analytical chemistry solutions that align with your drug development and regulatory strategy.
Our Flexible Approach
As a full-service drug development partner, CMC Pharma provides analytical chemistry support that is fully integrated with a suite of pharmaceutical development lab services. Our flexible model ensures you are not limited to a single dosage form, manufacturing site, or testing approach, and we offer non-GMP feasibility and characterization studies in our laboratory for early stages.
We prioritize quality and regulatory compliance by offering cGMP-compliant analytical testing and development services. Our laboratories are fully equipped to perform Good Manufacturing Practice (GMP) testing, ensuring that pharmaceutical products meet the stringent standards required by regulatory authorities, including the FDA and other global agencies.
Our cGMP lab testing capabilities support batch release and stability studies providing the robust data necessary for regulatory submissions. With analytical method validation services and state-of-the-art instrumentation, we ensure the accuracy, reliability, and reproducibility of test results.
CMC Pharma has a team of analytical chemists who are experts in method development, validation, and execution.
This includes the development of analytical methods by U/HPLC/ LC-MS and other techniques, as well as the development and validation of potency and related substances with stability-indicating methods.
- Equipment Includes:
- UHPLC
- ICH Stability Chambers
- UV/Vis Spectrophotometer
- Karl Fisher Titrator
- Osmometer
- Analytical Balances
- Glove Boxes
- Balance Enclosures
- Tap Densitometer
- Flowability Meter
- Dissolution Apparatus (App II, App IV)
- And More
Explore Our Other Drug Development Services:
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Contact Us Today and find out how CMC Pharma can help you!
Whether you need to develop robust analytical methods or require routine testing, Contact CMC Pharma to learn how we can help you advance your development program.
Send us a message or give us a call at 440-485-1734